The present invention relates to providing hydration opportunities for humans and animals.
The present invention relates to a manner in which active and non-active ingredients are delivered orally and/or via enteric hyper-alimentation through a nasal-gastric and/or gastrostomy tube for humans and animals.
More particularly, the present invention relates to a delivery form for beneficial and/or diagnostic agents with or without a support member(s), structure(s), material(s) and/or the like with, the intent and/or designed specifically for permitting such administration with or without functional and/or decorative elements.
Additionally, this invention covers the ability to customize product to better address individual needs, desires, etc. Further incorporating, as specified, various methodologies along with ingredient delivery technologies including but not limited to ones ranging from those that are flash delivered to, and/or those that are governed by controlled release technologies, for humans and/or animals.
Another part of the invention is directed towards diagnostic agents through drinking where by it is possible to present with or without a health-enhancing component, with or without a support member.
Animals, mostly domestic pets, are often forgotten when it comes to supplying, as an example, healthier alternatives. This is not always intentional especially with tight budgets and time restrictive schedules of “working” owners or in the case of large families, etc. The ability to bring to market products just for human consumption alone is most difficult, lei alone for pets and/or other animals.
Further covered is the ability to bring forth the invention with one or more value added and/or value perceived components such as: entertainment, education, advertising, promotions, and the like. An extension of the just aforesaid would be to incorporate active, reactive, and/or interactive abilities through toys, games, contests, which may have manual and/or power operating capabilities which provide movement, light, noise, and the like.
The goal of the invention extends beyond the delivery of ingredients into liquid for the ultimate goal of consumption by humans and/or animals.
The goal of the invention includes business method(s), model(s) and/or opportunities to open new avenues and/or venues of the distribution of product for sale and/or “give for free” product while, alone and/or simultaneously, providing a research and/or test market forum and/or the like.
The inventor calls attention to a line from one of the songs from Fiddler on the Roof, whereby much of the invention is embodied:
“A bird and a fish can fall in love but where are they going to live”.
In broad language, this invention represents thirty years of devotion to finding new; novel, creative, ways of bringing health-enhancing scientifically proven and ethical ingredients to the consumer through drinking; and then further expanding the thought as to how to bring the aforesaid to the general public.
While acknowledging the famous bell shaped curve the inventor is desirous of addressing individual needs, and wants, and is further desirous of deviating from the “one-size fits all” approach which, on a one to one basis, this is not that difficult or even impractical. It does however become quite difficult, perhaps even impossible, to take such a concept forward to the general public so that the public as a whole can benefit.
In our society, especially today, it is not realistic, possible, and/or practical to fabricate, mainly a ready to drink (RTD) beverage, to meet a multiplicity of the aforementioned individual needs and/or preferences of any type.
Even if the above were to be accomplished the United States alone is so large without even considering the rest of the world, that specialized production facilities (bottling plants), shipping (size, weight), and stocking in limited valuable venues, an enormous number of special RTD beverages is just short of impossible yet alone practical.
The beverage business is enormous; and so are its subdivisions, such as; wine, beer, soft drinks, sports-drinks, tea, coffee, water, and now new-age categories, etc. In total and/or in part it has an infrastructure of its own which doesn't always allow much room for creativity without a tour de force, a handsome price tag, yet alone the introduction/production/distribution of what the inventor most commonly calls “better health through drinking” concept/principle: make it healthy and make it clean/safe. It is also vital in today's world to make it convenient.
Ergo the following invention: Method of hydration, infusion system(s), support member(s), delivery system(s), and method(s): with business models, methods and opportunities.
Considering that there are many interwoven and overlapping aspects of this invention, the inventor believes that certain background information while maybe not essential will be most relevant for a better understanding of some of the main aspects of the invention. The inventor chooses to present:
1. INFUSION PACKETS: Infusion packets in general, for the foundational understanding;
2. HYDRATION: The importance of hydration, as liquid (mainly water) is a necessary constituent to render the activity of the infusion packet(s) and ultimately the liquid for consumption.
3. SOLUBLE FIBER: It is well known, and accepted in the general health professional community, that fiber is absolutely essential for optimal health. Further dietary fiber, mainly soluble fiber, has been stressed by several health organizations of the Federal Government. The Dietary Guidelines for Americans published jointly by the U.S. Government Department of Agriculture and Health and Human Services, and the National Cancer Institute recommend that all American's increase their daily intake of fiber. Health care professionals conclude that the American diet provides only about half of the suggested daily requirement of 25-35 grams.
4. TOO MUCH SUGAR: The overwhelming need to reduce the amount of sugar, which is so prevalent in today's beverages, is a goal of this invention;
5. COATINGS and ENCAPSULATIONS: A coating may be defined as a layer that covers a surface. Coatings have existed since the ninth century with the introduction of silver and gold coatings of pills in medicine. A fine powdered talcum, called pearl coating was popular at one time, Gelatin introduced in 1838, sugar in France in 1842 and twelve years later in the U.S. And about 1890 enteric-coated pills were introduced. This invention covers any and/or all enrobements, which provide a function even if that function is only decorative. Encapsulation technologies, including but not limited to liposomes, may better serve this invention but coated, enteric coated, encapsulated, and/or any enrobing technology may be used simultaneously and/or individually by design and/or intent. Encapsulations, are important not only for protecting sensitive ingredients, but also for masking certain aromas and negative tasting agents. Further, the inventor believes that the high sugar content of so many of the beverages can be reduced by employing any and/or all of the just aforementioned.
6. INGREDIENT INFORMATION: Information, ergo knowledge, as related to some valuable scientifically proven agents, other than soluble fiber, demonstrating to the reader the importance/need of new delivery vehicles as well as new business methods.
In relation to infusion packets, the background presented is particularly related to tea along with the enveloping material commonly known as the tea bag. The discovery of tea and the subsequent invention/development of the tea bag are perceived to be foundational for a comprehensive understanding of the invention set forthwith.
It is further essential to fully incorporate, and to fully understand, the importance of hydration mainly through the adequate consumption of safe pure water.
Not only are we a dehydrated society but we are a society of overly refined foods presenting very little if any in the way of fiber. While there is both insoluble and soluble fiber, the later is what is addressed here. The importance of water and soluble fiber is detailed in U.S. Pat. No. 6,248,390 to same inventor, Stillman, titled Fiber-Water: Water containing soluble fiber which patent is incorporated herein by reference.
This invention in total and/or in part has been fabricated for use in liquid; more specifically water, and hopefully, when possible, Fiber-Water™. Regardless of the liquid used, and with the existence of Fiber-Water (test marketed under FiberWater™ PerformanceWater™ by FiberWater International during the past year and a half) the invention may be so modified as to include, when desired, one or more additional soluble fibers thus adding and enriching the invention Fiber-Water (Performance-Water) and/or water, and/or any opaque and/or clear liquid (mainly water) but also milk regardless of source (cow, goat, soy, whey, etc.), soups, bullion, consommé, broth, stock and/or the like.
1. Infusion Packets
Infusion packets, water permeable coverings containing dried plant materials (e.g., a tea bag), have long been used to prepare infusions of various botanical origins. Tea is probably the most common constituent found in infusion packets.
Of historical note, tea is nearly 5,000 years old and was discovered, as legend has it, in 2737 B.C. by the Chinese emperor, Shen Nong, who was both a skilled ruler and a creative scientist, required all drinking water to be boiled for hygienic precaution. One day as he stopped to rest and the servants began to boil water; dried leaves from a nearby bush fell into the boiling water whereby the brown color was extracted from the leaves and permeated the water. Even the curious scientist the emperor was interested and drank the resulting liquid. He found it remarkably refreshing and so tea was born.
In the 1600s, tea became popular throughout Europe and the American colonies. In 1904, iced tea was created at the worlds fair in St. Louis.
Legend has it that, as tea was an accidental discovery, so was the tea bag. Tea traders, who began selling tea, in silk bags, invented the tea bag. Some customers dispensed with the step of opening the bags to obtain the tea within and simply dipped the entire bag into boiling water to prepare tea. Thomas Sullivan, a New York businessman, actually invented the modern tea bag in 1908. He started shipping samples of his teas in small silk bags for customer's approval. He noted that many customers actually preferred the samples because the tea bags were easier to use than loose tealeaves. The practice of putting tea into tea bags has given rise to one of the world's most creative packaging ideas.
The general notion of the tea bag is that an aliquot of herbal material is placed within a permeable package and dunked into a liquid—mostly commonly hot water. The hot water, and/or a hot liquid, thus allows the various constituents to transfer more easily from the permeable package into the liquid. This is in addition to the egg-shaped, perforated, usually metal and/or ceramic containers for tealeaves to be submerged into cups and/or teapots for the preparation of tea. Further, there exist filtering inserts (usually funnel-shaped members) that are positioned, clamped into a holder and ready to receive the tealeaves.
Tea breaks down into three basic types: black, green, and Oolong, which is popular in China and is partly oxidized. In the U.S., over 90% of the tea consumed is black tea, which has been fully oxidized or fermented. Green tea skips the oxidizing step. Green tea is a staple in the Orient; now gaining popularity in the U.S. and other parts of the world due in part to recent scientific studies linking green tea drinking with reduced cancer risks. U.S. Pat. No. 6,168,795 to Djang (Sante International Inc.) discloses a method for anticancer therapy using an herbal extract composition including green tea.
While flavored teas evolve from these three basic teas, herbal teas, more often than not, contain no true tealeaves. Herbal and medicinal teas are usually created from the flowers, berries, peels, seeds, leaves, and roots of many different plants. The herbal materials placed within an infusion packet are usually selected to impart active ingredients, interesting color, aroma, and flavor to the infused liquid. To this end, flavorful or fragrant materials such as citrus peels, flowers, and/or herbal materials such as mint, and jasmine are frequently used.
However, infusion packets are also known to provide sources of “functional” or medically active ingredients as exemplified by a leading herbal tea company, Traditional Medicinals is a company which produces over thirty different herbal teas to meet a wide variety of health needs. Their product line includes Think-O2 with Ginkgo biloba, an herb proven safe for mental alertness and memory; Echinacea Plus tea for when a cold or the flu starts; Throat Coat contains Pau d'Arco to coat the throat and “a double bang of American Ginseng for an extra big kick”.
From the first used tea bag going forward the tea bag has undergone many improvements both in materials to exotic crimping methods for closing the seams without adhesive or sewing. Literature is replete with various methods, designs, fabrications etc. designated to address better infusion. U.S. Pat. No. 5,674,544 to Shakespeare, (Tidy Tea Limited GB), discloses a compressible infusion package using a drawstring method to address better delivery/infusion. Another drawstring method is reflected in U.S. Pat. No. 5,951,452 to Stevenson, (Tetley GB Limited). Another to U.S. Pat. No. 5,989,602 to Drury and Dante, (Lipton) uses a drawstring whereby allowing the tag card to be detached to draw out further portions of the drawstring to contract the packet and squeeze out excess moisture after infusion. It has been noted that most all basically commercially sold tea bags and/or infusion packets are relatively the same shape while sizes may vary. The usual shape is square or slightly rectangle. Recently some round shapes are on the market looking like a filled pancake. U.S. Pat. No. 5,910,247 to Outterside reflects a two element filter bag which includes a cylindrical outer element a generally tubular inner element. Other shapes of noteworthiness are in the flow through category. These are functional having been designed for better infusion and no relation to creative appeal. U.S. Pat. No. 5,366,741 to Van Der Zon (Thomas J. Lipton Co. NJ), teaches a V-fold thus creating a duel compartment tea bag. Another U.S. Pat. No. 5,852,917 to Romagnoli (I.M.A. Industria Machine Automatiche S.p.A. (Bologna IT), titled Method of manufacturing double-chambered infusion bags by folding.
Later came the advent of different materials for the construction of the tea bag. U.S. Pat. No. 5,601,716 to Heinrich and Roland, (Papcel of Gernsbach, Del.), discloses a filter material a composed of both natural and synthetic plastic fibers.
Infusion packets, for the purpose of this invention, might contain tea and/or one or more of the properties of tea but not exclusively whether in the same and/or segregated compartment(s), with or without one or more support members.
2. Hydration and the Importance of Water
The inventor cannot stress enough the importance of hydration. Perhaps best stated by medical description: water is the media for biochemical reactions, is required for expiration, moistens air for breathing, protects and cushions vital organs, helps the body absorb nutrients, removes wastes, cushions joints, carries oxygen and nutrients to all cells in the body and provides an efficient cooling effect. Further, the human body contains between 55-75% water depending on the ratio of body fat to muscle. The human brain is 75% water; blood 92% water, muscles are 75% water, bones 22% water. When dehydration occurs the following symptoms may present: vagueness, discomfort, increased pulse, nausea, dizziness, headache, labored breathing, walking difficulties, twitching, and ultimately when ½ to 2 liters of fluid are lost it can be life threatening. When organs are 5% dehydrated, negative changes begin to occur. A 2% reduction in hydration equals a 7% reduction in endurance. Dr. John Greenleaf, NASA, in U.S. Pat. No. 5,447,730 and additional authored literature addresses the importance of hydration. Dr. Greenleaf further notes that when organs are 5% dehydrated negative reactions begin to occur. The readers attention is drawn to “Problem: thirst, drinking, behavior, and involuntary dehydration” by John E. Greenleaf (Medicine and Science in Sports and Exercise, 24:645 (1992).
A survey of 3,003 Americans, released on May 11, 1998 by the Nutrition Information Center at The New York Hospital-Cornell Medical Center the International Bottled Water Association, found that “most Americans are probably only getting about a third of the valuable hydration benefits they need” says Barbara Levin, R. D., Ph.D., of the center. “The vast majority isn't drinking enough water to begin with, and, to make matters worse, many don't realize that beverages containing alcohol and caffeine actually rob the body of water.”
According to the March 1994 issue of the Canadian Medical Journal, studies have shown that an increase in water intake can actually reduce fat deposits. Drinking enough water is the best treatment for water retention. Since water is the key to fat metabolism, it follows that the overweight person needs to drink more water. Although as stated, on the average, a person should drink 8 (eight), 8 oz. (240 ml.), glasses every day the overweight person needs one extra glass for every 25 pounds of excess weight.
According to the Journal of the American Dietetic Association (ADA): Vol. 99, No. 2, February 1999, in the article titled: “Water: An Essential but Overlooked Nutrient”: new research indicates that fluid consumption in general, and water consumption in particular, can have an effect on the risk of urinary stone disease; cancers of the breast, colon, and urinary tract; childhood and adolescent obesity; mitral valve prolapse; salivary gland function; and overall health in the elderly.”
Further, recent literature brings forth the fact that heartburn may be a cause of dehydration in the upper gastrointestinal tract. Additional literature points to the fact that rheumatoid joint pain/arthritis may be a signal of water shortage in the painful joint. Low back pain and ankylosing arthritis of the spine may be signs of water shortage in the spinal column and discs, the spinal cushions that support the weight of the body. Angina can be a sign of water shortage in the heart/lung axis. Migraine headaches may be a sign that the brain and the eyes need more water. Colitis may also result from a water shortage in the large gut. Asthma, which also affects 12,000,000 children and kills several thousands of them every-year, may be due to a complication of dehydration of the body. High blood pressure, hypertension, is a state of adaptation of the body to generalized drought, when there is not enough water to fill all the blood vessels that diffuse water into vital cells. Both diabetes and elevated cholesterol levels have thought to represent an adaptation to insufficient water in the body. Additional conditions that may be caused by prolonged chronic dehydration are Depression, Loss of libido, Chronic Fatigue Syndrome (CFS) Lupus, Multiple Sclerosis (MS), Muscular Dystrophy (MD), and more.
Dieticians, health care professionals, caregivers, (especially parents) should encourage through education and various activities the desire to design and implement a fluid intake plan.
Thus far, this invention has paid much attention to the general population, much attention to the younger population but not as much focus to our seniors who, at the other extreme, begin to act like children. The inventor is concerned with dehydration amongst this group as a growing population as well and, often times, their lack of desire for hot liquids especially in the summer time. Older people are less likely to drink sufficient water, and hence, are more likely to suffer from dehydration. Once dehydration begins, the thirst response becomes even less effective as one ages, according to Dr. John E. Greenleaf, of NASA, (Medicine and Science in Sports and Exercise, 24:645 {1992}). The reason for this change is not known.
Because the inventor is desirous of providing a vehicle geared towards ensuring proper hydration and the known fact that the invented infusion system must have a liquid, mainly water, to render active, much in the way of a health enhancing liquid can now be produced for the consumer.
U.S. Pat. No. 6,212,959 to Perkins also stresses the importance of hydration noting the following: each person under normal conditions should drink at least 8, (eight), 8 oz. (240 ml) glasses of water a day. This is because fluids are continually lost from the body at varying rates throughout the day, the rate of loss increasing during exertion. Serious consequences result if this water is not replaced in the proper amount and at the proper time. These consequences include fatigue, nausea, loss of consciousness, and, potentially, death.
3. Soluble Fiber
Unquestionably as a society, we are suffering from a deplorable lack of dietary fiber. We are constantly warned by the medical profession, and other experts, that this lack of fiber can, and does, kill. Our diets are replete with “empty” calories—refined foods loaded with fats and sugars—and contain few whole foods. When it comes to fiber, many believe that a daily bowl of cereal is adequate. Our supermarkets and pantries are stuffed with brightly packaged, overly refined, and prepared foods that are usually fiber-free or very low in fiber. The presence or absence of dietary fiber greatly influences one's ability to expel solid wastes. It has been estimated that about one in 19 individuals in our society has a health condition that requires special attention. In many cases, this makes the need for adequate fiber and water, even more important to these individuals. Due to modern medicine's success in combating contagious disease, and with a better understanding of aging and our ability to address medically the aging process, we are living longer. Nevertheless, can we live healthier?
Fiber or “roughage” is a component of food that remains undigested as it passes through the gastrointestinal system. The vast majority of dietary fiber consists of polysaccharides of plant origin. The most obvious fiber is the cellulosic wall that surrounds plant cells. Many of these cells are actually called “fibers”, hence the name “fiber” for this dietary component. However, there are actually two forms of fiber: insoluble fiber—the classic cellulosic material, and soluble fiber—water soluble polysaccharides that are not digested by human or carnivore digestive systems. Both types of fiber bind considerable water and thus, have a softening effect on the stool. However, soluble fiber may, depending on the precise polysaccharides involved, be metabolized or partially metabolized directly by bacteria in the colon. Both types of fibers tend to increase motility within the gastrointestinal tract thus speeding transit time of wastes and lowering the risk of acute and chronic medical problems. Like water, fiber is essential for human health and is not metabolized by humans.
It has been discovered that dietary fiber appears to moderate the rate at which sugars and fats are absorbed from the intestine. The exact reason for this effect is not completely understood. In the case of simple sugars, slowed absorption translates to a more gradual rise in blood sugar following eating. This is important in the managing of diabetes and may also help prevent adult onset diabetes. In the case of fats, the fiber seems to help prevent damaging levels of cholesterol in the blood. This seems to be due to a binding of bile salts and cholesterol to the fiber so that these materials are excreted with the feces rather than being absorbed or reabsorbed. Studies show adequate fiber clearly lowers the risk of heart disease and tends to bind toxins, including toxic metals, allowing them to exit safely from the digestive system.
Soluble fiber is now known to address various forms of cancer such as prostate, rectal, and colon cancer. Reuters (London) Jun. 26, 2001 News report stated: High fiber diet can cut cancer risk of colorectal cancer by 40% according to Dr. Sheila Bingham of the Dunn Human Nutrition Unit at Cambridge, London. Noting the complete study will be published late fall 2001.
Further soluble fiber has been shown to stabilize blood sugar by moderating the rate of carbohydrate absorption from the digestive tract and thereby ameliorate swings in blood sugar. This can also translate to mood swings. Additionally this slowing the rate of digestion (transit time through the colon) serves to curb appetite, prevent weight gain, and prevent obesity.
Soluble fiber is known to retard the absorption of lipids and lower serum cholesterol and triglycerides, thus reducing the risk of heart disease.
Soluble fiber supports the good gut micro-flora and supports regularity thus minimizing the absorption of potentially dangerous toxins (e.g., carcinogens and heavy metals); also, soluble fiber binds to bile salts and help decrease the risk of gallbladder disease, while also serving to support and promote bowel regularity.
Additionally arabinogalactan, a non-starch polysaccharide (NSP), has been classified as a dietary fiber by the Food and Drug Administration (FDA) since it resists digestion by enzymes of the saliva and the small intestine. It enters the large bowel intact, where it is fermented by resident micro-flora. It is similar to gum Arabic because it is highly branched. Arabinoglactan is produced from Western Larch trees by LAREX™ (St. Paul. MN). Experimental research indicates that it stimulates natural killer cell cytotoxicity. It may be cytotoxic to tumor cells and virus-infected cells, and therefore potentially therapeutic for a variety of diseases. It has already been shown to have properties capable of stimulating the immune system.
Of specific importance to diabetics high soluble fiber intake improves glycemic control, as evidences by decreases in the mean daily postprandial rise in glucose. (The New England Journal of Medicine, May 11, 2000, p. 1392-1398.) Conclusions: A high intake of dietary fiber, particularly of the soluble type, above the level recommended by the American Diabetic Association (ADA), improves glycemic control, decreases hyper-insulinemia, and lowers plasma lipid concentrations in patients with type 2 diabetes.
Soluble fiber comes from a wide range of plant sources. Water-soluble plant pectins and pectic materials, galactomannans, arabanogalactans and water-soluble hermicelulose can act as soluble fiber. Many plant “mucilages,” gums, and soluble polysaccharides found in grains, seeds, or stems such as psyllium, guar, oat (beta glucans), astragalus (gum traganth), gum ghatti, gum karaya (Sterculia gum), and gum acacia are also soluble fiber. Algal polysaccharides such as agar or carrageenan also behave as soluble fiber as do other indigestible carbohydrates, such as maltodextrins or dextrins, produced by chemical or enzymatic digestion (e.g., partial hydrolysis) of starch, gums and other carbohydrate polymers. Soluble cellulosic ethers and other derivatives such as carboxymethyl cellulose behave as soluble fiber as do indigestible carbohydrate polymers artificially prepared using bacterial enzymes. Non-digestible storage carbohydrates, such as inulin are also important soluble fibers. A number of companies are now providing an entire range of “soluble fiber” materials. For example TIC Gums of Belcamp, Md., Novartis Nutrition of Minneapolis, Minn. and Imperial Sensus of Sugar Land, Tex. provide soluble fiber compounds of food grade.
Soluble “fiber” is known to provide a novel opportunity for improving the characteristics of fiber-poor refined foods. Fiber was removed from food products because in many cases it made the foods coarse, unpalatable or difficult to process. Adding insoluble bran or other similar fiber to foods may provide more roughage but can also degrade the favorable properties of the foods. For example, cakes or pastries made from flours high in insoluble fiber may have inferior taste and texture. Excess insoluble fiber may upset the digestion and lead to a number of digestive problems.
On the other hand, soluble fiber is generally well tolerated, often improves the texture, and/or other physical characteristics of the food product and is generally innocuous. Consequently, there are a growing number of food products, ranging from baked goods to “shake-like” beverages, contain added fiber in the form of soluble fiber.
Can we not only restore the benefits of fiber, herein soluble fiber, to our highly refined diet but also significantly affect the final product totally and/or in part by the texture and/or the viscosity, and/or the mouth feel of the liquid. This can also be beneficial to the absorption rate and/or flow rate both by mouth and or tube feedings.
These benefits are well known for humans but are also available to animals that have digestive systems substantially similar to humans (e.g., dogs, cats and some other domestic animals). Therefore, the current invention is useful for these animals as well as for humans.
While the invention does not specifically state that soluble fiber, from one or more sources must be present, it is to be considered “a good idea”.
The present inventor has realized that a properly formulated infusion packet is the ideal vehicle for administering nutritional supplements such as soluble fiber either independently, and/or with color, and/or with flavor and/or in consort with other pharmaceutical and/or nutritional additives.
4. The Need to Reduce Sugar in Beverages
America is drowning in sugar. The Center for Science in the Public Interest (CSPI) and dozens of leading health experts and organizations have petitioned the Food and Drug Administration (FDA) to require that food labels declare how much sugar is added to soft drinks, ice cream, and other foods.
Most prevalent in beverages today, other than those which are artificially sweetened is sugar and lots of it. Sugar is not on the “good for you” list in our health conscious society today yet the big companies with their tremendous advertising budgets use signage, popular movie, television, and recording personalities to help sell their products especially to a population which is impressionable, doesn't read and/or are uneducated or not responsible.
Further, many of the older population, senior citizens, do not understand this. Many popular beverages avidly consumed by seniors are high in sugar. For the most part, they have grown up with many of them.
5. Coatings and Encapsulations
For further reference on coatings the inventor notes; U.S. Pat. No. 5,024,824 to Edgren, et al. (Alza Corporation Palo Alto Calif.) titled Annealed coats dosage form is disclosed comprising a coat that surrounds a drug. The coat comprises a sub-coat and an overcoat thermally annealed to provide a single unit coat around the drug.
Micro-encapsulation is the process of enveloping certain drugs, enzymes, and the like in polymeric matrices designed to be used in controlled release or delayed release applications.
The International Micro-encapsulation Society, founded in 1995, Glasgow, is dedicated to foster and promote communication and collaboration between amongst science professionals. They define micro-encapsulations as a process that allows liquid or solid substances to be covered by a barrier wall. The wall must be chemically inert to the content of the capsule and possess an adequate stability to mechanical, thermal, or chemical influence. Various barrier wall materials may be utilized during encapsulation, which are dependent upon the application.
Encapsulations, which release their contents within the packet so that the released active is transported across the membrane, may be included. Used this way the shells or the encapsulating material will remain in the packet. A visual might include hatched eggs whereby the little chick goes through the screen/mesh/pores but the shells of the egg remain in the hen house.
Alternatively, the entire encapsulation pass through the membrane intact and release the encapsulated active and/or non-active ingredient(s) into the infused liquid either before or after ingestion of the infused liquid. It is conceivable that there be a combination of the aforesaid and the to be said within one system.
Additionally the encapsulations may be timed released, and even on an individual basis of each encapsulation, so that the ingredient(s) may be released in the mouth, or anywhere along the digestive tract within a specified period, most likely one to three hours after ingestion.
Further the encapsulations, under the aforementioned timed release, may be totally contained within the membrane of the packet and/or partially contained within the membrane in any ratio, size, color, shape, desired relative and/or decorative to the packet and/or to interior ingredients. This would fall under what the inventor calls “best use” of active ingredients. This can also apply to color encapsulations and/or aroma encapsulations as to the formulas just mentioned and to those skilled in the art of.
The Wurster process is a coating technique that is well suited to uniformly coat or encapsulate individual particulate materials. The Wurster process is an internationally recognized coating technique for precision of film coat to particulate such as powders, crystals, or granules.
The coating of pharmaceutical and/or nutraceutical micro-encapsulations helps ensure and/or optimize stability and/or prolong shelf life of active, non-active and/or reactive ingredients.
Capsules may be coated for improved barrier properties. Coating is a most effective way of masking the taste or odor of a particular ingredient, making products more palatable. Enteric coatings can be adjusted most easily to controlled and or timed release for the maximum health benefits.
In the food, industry micro-encapsulations are beneficial especially to encapsulate vitamins, minerals, and functional food ingredients. Additionally noted is that thin or partial coatings are very effective in reducing the caking of certain materials.
For example, Bio Dar was established in 1984 as a United States and Israeli joint venture now under Lyco-Red, Koor Group of Companies. They are specialists in microencapsulated vitamins and minerals for the fortification of food products. Their specialty extends to technologies of how to keep the food additive particle from imparting an undesirable taste to the surrounding ingredients. This technology is most valuable for where the micro-encapsulations are mixed in with the other ingredients. Further, they deal with Carnetine, Amino Acids, Herbal Extracts as well as other nutritional components where the role of micro-encapsulation is to avoid hygroscopicity, and/or minimize interactions and/or eliminate the oxidation of these materials etc. Further, they have the ability to do multiplayer micro-encapsulations for mainly drug delivery. U.S. Pat. No. 4,749,575 to Rotman, (Bio-Dar Ltd. IL), titled Microencapsulated medicament in sweet matrix.
Other patents of reference are U.S. Pat. No. 4,711,784 to Yang (/Warner Lambert; U.S. Pat. No. 5,024,842 to Edgren, Theeuwes (Alza Corp.); U.S. Pat. No. 5,051,261 to Mc Ginity, Chang (FMC Corp); U.S. Pat. No. 5,009,819 to Popescu, Mertz (The Liposome Compar); U.S. Pat. No. 5,653,996 to Hai (Genentech Calif.); U.S. Pat. No. 5,891,465 to Keller (Bio-Zone Laboratories Inc CA); U.S. Pat. No. 6,007,838 to Alving, Owens, Wassef, Nabila (U.S.A. Dept. of the Sec. of the Army, Washington D.C.); U.S. Pat. No. 6,190,591 to van Lengerich (/General Mills Minn.); U.S. Pat. No. 5,922,350 to/Janoff et. al. (The Liposome Company NJ); U.S. Pat. No. 6,174,554 to So (Nestic Vevey, C H) titled encapsulated liquid product; U.S. Pat. No. 6,258,870 to Hubbell et al. (Board of Regents of the University. of Texas Systems, Austin, Tex.) titled Gel for encapsulation of biological materials.
Significant to this invention is that the use of any and/or all types of encapsulations and encapsulation technologies be brought forth to augment infusion systems and/or infusion packets. This technology thus allows the unique combining and vehicle of delivering ingredients solely and/or in combination of hitherto.
As an example, incompatible ingredients so that infusion packets can readily deliver a variety of active agents including stabilized enzymes and similar labile substances. In some cases, the encapsulations can be designed to simply dissolve or burst and release their active contents right into the infused liquid. In other cases, the encapsulations can be designed to leave the packet intact and exist as colloidal particles suspended within the infused liquid. Such suspended capsules can then release their contents at the correct position within the digestive system of the person or animal consuming the infused beverage. Thus, an enzyme or ingredient sensitive to stomach acid would be released in the intestine to do its work in the proper milieu.
6. Ingredient Classifications with Descriptions:
Antioxidants
Antioxidants help to protect the body from the formation of free radicals. Free radicals can cause damage to the cells, impairing the immune system and leading to infections and various degenerative diseases such as heart disease and cancer. Free radical damage is thought by scientists to be the basis for the aging process as well.
The following antioxidants are a consideration of the inventor:                1. Alpha-Lipoic Acid helps to neutralize the effects of free radicals.        2. Bilberry is a strong antioxidant that keeps capillary walls strong and flexible. Supports and strengthens collagen, inhibits growth of bacteria, anti-inflammatory, anti-aging, anti-carcinogenic.        3. Coenzyme Q10 is an immunological stimulant, increases circulation; anti-aging, and beneficial for cardiovascular system.        4. Cysteine (an amino acid) detoxifier of alcohol, tobacco smoke, and environmental pollutants. Anti-aging.        5. Glutathione defends against damage from smoking, exposure to radiation, cancer chemotherapy, and toxins such as alcohol. A detoxifier of heavy metals and drugs, it aids in the treatment of blood and liver disorders.        6. Melatonin is an antioxidant/free radical scavenger        7. Selenium guards the cells of blood, heart, liver, and lungs. It stimulates antibody response to infection.        8. Vitamin C free radical scavenger. It increases the synthesis of interferon (natural antiviral substance produced by the body).        9. Vitamin E prevents the oxidation of lipids.        
Other antioxidants include, but are not limited to, Green Tea, Grape Seed Extract, Superoxide Dismutase (SOD), Vitamin A, Beta Carotene, and Zinc. The inventor envisions formulations of one or more antioxidants in combination with any other ingredient to be said or with consideration to all the aforesaid.
Biotics
In addition to the possible inclusion and careful selection as to source and standardization of vitamins, minerals, and herbals, the formulations for the infusion packets will be built around the groups commonly known as fiber, pre-biotics, pro-probiotics, antioxidants, amino acids, and both systemic and digestive enzymes.
Pro-biotics are organisms and/or substances that help to improve the environment of the intestinal tract. Pro-biotics are foods that contain live bacteria and are known to increase milk digestibility, speed recovery from diarrhea, enhance immune function, reduce certain cancers, and lower of blood cholesterol levels.
Pre-biotics are foods or nutrients that are used by specific bacteria and that can be added to the diet to increase the chances of these particular bacteria growing and thriving in the intestine.
The bacteria that live in the intestines make up a very large and very diverse population. The numbers of each kind of bacteria change depending on age, diet, health status, and use of drugs and supplements. The bacteria that do thrive do so because they are able to adhere to the intestinal wall and use the semi-digested food that is passing through the intestines. Because some bacteria have specific nutrient requirements, it has been proposed that adding these particular foods or nutrient to the diet could be a way of increasing the numbers of specific bacteria. This is important not just for humans but for animals as well.
U.S. Pat. No. 6,180,099 to Paul, (Metagenics), titled, “Method Of Using Immunoglobulin And Fiber-Containing Compositions For Human Health” identifies preferred and beneficial human intestinal microorganisms such as Lactobacillus acidophilus, L. bulgaricus, L. casei, L. fermentum, L. salivaroes, L. brevis, L. leichmannii, L. plantarum, L. cellobiosus, Bifidobacterium adolescentis, B. infantis, B. longum, B. thermophilum, and B. bifidum. More preferably, the beneficial human intestinal microorganism is selected from L acidophilus and B. adolescentis. 
Pro-biotics and pre-biotics are delicate and sensitive and up until recently, have not been able to be handled effectively long-term, without refrigeration. With new encapsulation technologies, especially the new micro-encapsulation technologies available today, we are now able to handle these organisms successfully. Not only are they valuable in human health but animal health as well.
Enzymes
Enzymes sustain life. The late Dr. Edward Howell, a physician and pioneer in enzyme research, called enzymes the “sparks of life”. These energized protein molecules play a necessary role in virtually all of the biochemical activities that go on in the body. They are essential for digesting food, for stimulating the brain, for providing cellular energy, and for repairing all tissues, organs, and cells. Life as we know it could not exist without the action of enzymes, even in the presence of sufficient amounts of vitamins, minerals, water, and other nutrients.
Enzymes are often divided into two groups: systemic and/or metabolic enzymes and digestive enzymes.
Digestive Enzymes
Digestive enzymes are secreted along the gastrointestinal tract and break down foods so that the nutrients are more readily absorbed into the bloodstream for use in various bodily functions. There are three main categories of digestive enzymes: amylase, protease, and lipase. Amylase, found in saliva and in the pancreatic and intestinal juices, breaks down carbohydrates. Different types of amylase break down specific types of sugars. For example lactase breaks down milk sugar (lactose), maltase breaks down malt sugar (maltose), and sucrase breaks down cane and beet sugar (sucrose). Protease, found in the stomach juices, and also in the pancreatic and intestinal juices, helps to digest protein. Lipase, found in the stomach and pancreatic juices, also present in fats in foods, aids in fat digestion.
Digestive enzymes are very important on a regular basis. While the body manufactures a supply of enzymes, it can also obtain enzymes from food. Unfortunately, enzymes are extremely sensitive to heat. (Even low to moderate heat (118 degrees F. (48 degrees C.) or above) destroys most enzymes in food, so to obtain enzymes for food one must eat raw foods. Unfortunately, the eating of raw food is not prevalent in out society today. Research has shown that as we grow older, the body's ability to produce enzymes decreases. At the same time, mal-absorption of nutrients, tissue breakdown, and adverse health conditions increase.
The alternative is to take enzyme supplements, which reduce the stress on the body. Today digestive enzymes are available over the counter in tablet, liquid, and capsule form.
It is the object of this invention to provide digestive enzymes, separately and/or in, combination with each other. If they are micro-encapsulated, there is a greater potential for stability and potency. Further, they may be combined with other ingredients to compliment such as peppermint which is know to be good for digestion.
Systemic Enzymes
Many people are familiar with enzymes as digestive aids. In addition it is very important to include the systemic enzymes and systemic enzymes in combinations because many enzymes can also be used to treat a wide variety of conditions through systemic enzyme therapy and/or through the aforesaid use of combinations.
Systemic enzymes can be taken in formulations made with any and/or all sorts of dietary supplements such as phyto-nutrients, vitamins, minerals, herbs, anti-inflammatory agents nutraceuticals, pharmaceuticals, etc. Again, development and combinations rely on the technologies to best deliver, while ensuring stability and bioavailability to the consumer. From the categories just described and mainly those which are considered “nutritive”, (especially phyto-nutrients those coming from plants), in combination with systemic enzymes form what is called and have been described as Enzyme Absorption System Enhancers (EASE). These combinations are beneficial as they improve the absorption and bioavailability of other nutrients, maximize enzyme activity when combined with these nutrients, reduce the drain of the bodies own digestive enzymes, etc.
In systemic enzyme therapy, the enzymes are distributed throughout the body to help restore the body to health. Some of the conditions which can be treated with systemic enzyme therapy include; arthritis (and other inflammatory conditions), back pain, premature aging, circulatory problems, herpes, injuries, systemic myofacial pain, multiple sclerosis (MS), skin problems, gynecological problems, lupus, erythematosus, and other auto-immune diseases, viruses, and weight problems.
There is much literature on the aforementioned coming from Germany, Japan, and Italy along with the US on the use of enzyme therapy. The inventor calls attention to the fact that in addition to new applications, which are being discovered constantly in systemic enzyme therapy they are being discovered in all categories whereby the delivery system becomes critical. Once again,
“If a bird and a fish fall in love where are they going to live”?
Amino Acids
Amino acids are the chemical units of protein. Assuming the reader knows the importance of protein it is not necessary for the inventor to elaborate. It is only relevant from which to go forward. Proteins are amino acids linked together to form peptide bonds. Each individual type of protein is composed of a specific group of amino acids.
In addition to combine to form the body's proteins, some amino acids act as neurotransmitters or as precursors of neurotransmitters. Further, amino acids enable vitamins and minerals to perform their job properly.
For certain effects, and certain disorders, taking supplements of specific amino acids can be very beneficial. When taking a specific amino acid or amino acid combination, it supports the metabolic pathway involved in a particular situation. Vegetarians, especially vegans, should consider taking a formula containing all of the essential amino acids to ensure that their protein requirements are met.
The inventor here forth presents a brief description of some of the amino acids. However, in contemplating the contents of the infusion packet invention one or more may be included. The chemical structure will be the L form. The delivery system used will be the most compatible to ensure potency and stability while realizing that the amino acids are stable at room temperature and decompose when heated to temperatures of 180° C. to 350° C.
With the information presented below it will be obvious to see the possible combinations of fiber, amino acids, antioxidants and the like in multiple formulations.                1. Alanine aids in the metabolism of glucose.        2. Arginine retards the growth of tumors and cancer by enhancing immune function. May benefit those suffering from AIDS and malignant diseases that suppress the immune system. Good for liver disorders, cirrhosis, fatty liver, detoxifying. Useful in treating sterility in men. Important for muscle metabolism. Aids in weight loss because it facilitates an increase in muscle mass and a reduction in body fat. Stimulates the pancreas to release insulin.        3. Asparagine maintains balance in the central nervous system (CNS).        4. Aspartic Acid increases stamina, further it is good for fatigue and plays a vital role in metabolism. Good for athletes. Beneficial for neural and brain disorders.        5. Carnitine is more a substance related to the B vitamins. Main function is to help transport long-chained fatty acids, burned within the cells to provide energy. Major source of energy for muscles. Increases the use of fat as energy.        6. Citrulline promotes energy, stimulates they immune system.        7. Cystein and Cystine help to detoxify and protect the body from radiation damage. Good for rheumatoid arthritis, hardening of the arteries and cancer. They promote healing after surgery and severe burns, chelate heavy metals and promote the burning of fat and the building of muscle.        8. Dimethylglycine. (DMG) helps the body maintain high energy levels and boosts mental acuity. It has been found to enhance the immune system and to reduce elevated blood cholesterol and triglyceride levels. It improves oxygen utilization by the body, helps to normalize blood pressure and blood glucose levels. It may also be useful for controlling epileptic seizures.        9. Gamma-Aminobutyric Acid acts as a neurotransmitter in the central nervous system. It can be taken to calm the body and used in treatment of epilepsy and hypertension. It is good for depressed sex drive and also useful for enlarged prostate, probably because it plays a role in the mechanism regulating the release of sex hormones. GABA is effective in treating attention deficit disorder.        10. Glutamic Acid increases the firing of neurons in the central nervous system. It is important in the metabolism of sugars and fats. It has been known to help to correct personality disorders and is used in the treatment of epilepsy, mental retardation, muscular dystrophy, ulcers, and hypoglycemic coma, a complication of insulin treatment for diabetics.        11. Glutamine promotes mental ability and the maintenance of a healthy digestive tract. It helps to build and maintain muscle; supplemental glutamine is useful for dieters and bodybuilders. It can be helpful in the treatment of arthritis, autoimmune disease, fibrosis, intestinal disorders, peptic ulcers, and connective tissue diseases.        12. Tyrosine is a precursor of the neurotransmitter norepinephrine and dopamine, which regulate mood, among other things. Tyrosine acts as a mood elevator. It suppresses the appetite and helps reduce body fat. It aids in the production of melanin (the pigment responsible for skin and hair color). Supplemental L-Tyrosine has been used for stress reduction. It has been used to help individuals suffering from anxiety, depression, allergies, and headaches as well as persons undergoing withdrawal from drugs.        13. Valine has a stimulating effect, and is also needed for muscle metabolism, tissue repair, and the maintenance of a proper nitrogen balance in the body. Valine is good for correcting the type of severe amino acid deficiencies that can be caused by drug addiction.        
Of course, additional amino acids can also be included as needed and/or desired.
In order to appreciate the importance and totality of this invention it valuable not just to acknowledge, as a sample: ingredient discoveries, ingredient matching to specific desires, needs, wants, conditions; production methods/processing; formulations, and or the like whether they be pharmaceuticals, nutraceuticals, dietary supplements and/or the like.
So here we sit with all this material and face the dilemma of how to bring all this to market safely, conveniently, economically etc. so that we cannot only address living longer but also living healthier and more enjoyably.
Hoping not to sound redundant, the inventor once again quotes “If a bird and a fish fall in love where are they going to live”? We need new, novel, and unique delivery systems taking into consideration all set forth by this invention and with a special bent towards being affordable, available, reliable, consistent, and the like especially being conscious of being most desirous of consumer appeal for compliance etc.
Listed below for illustrative purposes of the aforementioned statement, this inventor has selected three scientific, documented issued patents.                14. U.S. Pat. No. 5,849,324 to Dohnalek, et al. (Abbott Laboratories, Abbott Park Ill.) titled Use of indigestible oligosaccharides to reduce the incidence of otis media in humans. Prevention of otitis media (ear infections) in young children is a significant public health problem that has not been solved. The methods that are presently available are limited to practices that; reduce transmission of infectious agents; especially to susceptible individuals. Such methods include provision of clean water (for which this invention supports) hand washing, and good personal hygiene. Additionally, treatment by and large has been with anti-biotics for which we sometimes create another problem, and that is colonizing an individual with anti-resistant bacteria. Note: The development of vaccines has thus far been limited due to the large number pathogens that can cause this disease, and because young children, who are at the greatest risk, often fail to develop effective immunity.        15. U.S. Pat. No. 6,008,253 to Meglasson (The Upjohn Company (Kalamazoo, Mich.), titled Use of 3-guanidinpropionic acid to increase endurance, stamina, and exercise capacity in a mammal. The present invention provides a new food product and use for a known compound. With a careful examination of the Meglasson patent, it should become obvious that by this invention a new delivery system is now possible. The claims include not just what is mentioned in the title but to further treat excess adiposity in a mammal in need thereof; or treat non-insulin dependent diabetes mellitus (NIDDM). Later in the content is mentioned regulating a dosage regimen to the weight of the patient (showing individuality) and sustained release form deliver. The Upjohn Company describes sustained release as a formulation in which the drug becomes biologically available to the patient at a measured rate over a prolonged period. Such-compositions being well known to those skilled in the art.        16. U.S. Pat. No. 5,578,304 to Sipos (Digestive Care Inc. Lebanon N.J.), titled, Composition of digestive enzymes and salts of bile acids and process for preparation. Disclosed herein are gastric acid-resistant polymer-coated and buffered digestive enzymes etc. for the treatment digestive disorders, pancreatic enzyme insufficiency, impaired liver function, cystic fibrosis, for dissolving gallstones, regulating dietary cholesterol absorption.        